Validation of the predictive value of BDNF -87 methylation for antidepressant treatment success in severely depressed patients – a randomized rater-blinded trial

Not Applicable

• Conditions: F32.2; F32.3; F33.2; F33.3; Severe depressive episode without psychotic symptoms; Severe depressive episode with psychotic symptoms; Recurrent depressive disorder, current episode severe without psychotic symptoms; Recurrent depressive disorder, current episode severe with psychotic symptoms

• Registration Number: DRKS00032503
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

Severity of symptoms: Severe (HDRS-24 = 25)
- Change of therapy / alteration of medication therapy
- First depressive episode before the age of 50
- Signed informed consent
- Capacity to provide consent

Exclusion Criteria

- Acute suicidality
- Involuntary placement according to state law (e.g., §16/17 Nds. PsychKG)
- Persistent depressive disorder (PDD)
- Following diagnoses in medical history: Dementia, schizophrenia, schizoaffective disorder, bipolar disorder, substance dependence with current necessary detoxification
- Simultaneous participation in other clinical studies not conducted within the scope of the P4D project

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Two (co-)primary endpoints:<br><br>1.: Co-primary Efficacy Endpoint: Remission rate of depressive symptoms 6 weeks post-randomization determined by an HDRS-24 total score = 10.<br><br>2.: Co-primary Tolerance Endpoint: Rate of adverse events (AE) within 6 weeks post-randomization.

Secondary Outcome Measures

Name	Time	Method
Remission 10 weeks after randomization (HDRS-24 total scores = 10), adverse events 10 weeks after randomization, prescription rate of antidepressants, frequency of changes in therapy regimens during study participation; frequency of specific psychotherapy application; frequency of additional treatment options' utilization; frequency and reasons for study discontinuations; attitudes (acceptance, fears, and prejudices) towards biomarker-guided investigations and technical procedures in the population (representative population survey). Patient-physician relationship.